study to evaluate switching from a regimen of two nucleos(t)ide reverse transcriptase inhibitors (nrti) plus a third agent to a fixed dose combination (fdc) of bictegravir/emtricitabine/tenofovir alafenamide (b/f/taf), in virologically-suppressed, hiv-1 infected african american participants

Conditions: HIV-1 Infection

Summary: the primary objective of this study is to evaluate the efficacy of switching from a regimen of 2 nucleos(t)ide reverse transcriptase inhibitors (nrtis) and a third agent to a fixed dose combination (fdc) of bictegravir/emtricitabine/tenofovir alafenamide (b/f/taf) versus continuing their baseline regimen in hiv-1 infected, virologically suppressed african american participants.


Eligibility criteria:
key inclusion criteria: * self-describes as black, african american, or mixed race, including black * currently receiving an antiretrovirals (arv) regimen other than fdc of b/f/taf that consists of any two nrtis + allowed 3rd agent for ≥ 6 months * allowed 3rd agents include any fda-approved insti, with the exception of bictegravir, any fda-approved nnrti with the exception of etravirine, protease inhibitors or the ccr5 antagonist, maraviroc * if the baseline 3rd agent is dolutegravir, dosing other than 50 mg once daily is excluded * baseline regimens containing investigational drugs or \> 2 classes of arvs are not permitted, with the exception of the pharmacologic enhancers cobicistat (taken with elvitegravir or a pi), or ritonavir (taken with a pi) * have no documented or suspected resistance to instis and no history of virologic failure on an insti containing regimen (2 consecutive hiv-1 rna ≥ 50 copies/ml after achieving \<50 copies/ml while on an insti-containing regimen) * history of 1-2 thymidine analogue mutations (tams), m184v/i, and any other rt substitutions are allowed, with the following exceptions: history of 3 or more tams (m41l, d67n, k70r, l210w, t215f/y, and k219q/e/n/r), t69-insertions, or k65r/e/n in rt will be excluded * documented plasma hiv-1 rna \< 50 copies/ml during treatment with the baseline regimen for a minimum period of 6 months and at least the last two hiv-1 rna measurements prior to the screening visit * hiv-1 rna levels \< 50 copies/ml at screening * estimated glomerular filtration rate (egfr) ≥ 50 ml/min according to the cockcroft-gault formula for creatinine clearance key exclusion criteria: * history of 3 or more tams (m41l, d67n, k70r, l210w, t215f/y, and k219q/e/n/r),t69-insertions, or k65r/e/n in rt * no desire to switch from current arvs * an opportunistic illness indicative of stage 3 hiv diagnosed within the 30 days prior to screening * participants experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, or variceal bleeding) * have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies) * malignancy within 5 years of screening other than cutaneous kaposi's sarcoma, completely resected non -melanoma skin cancer (basal cell carcinoma or non-invasive cutaneous squamous carcinoma), or completely resected carcinoma in-situ of the cervix (cin 3) or anus (ain 3). a prior malignancy treated with curative therapy and for which there has been no evidence of disease for at least five years prior to screening is allowed * current alcohol or substance use judged by the investigator to potentially interfere with participant study compliance * active, serious infections (other than hiv-1 infection) requiring antibiotic or antifungal therapy within 30 days prior to day 1 * participation in any other clinical trial, including observational studies, without prior approval from the sponsor is prohibited while participating in this trial * any other clinical condition or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to comply with the dosing requirements * known hypersensitivity to fdc of b/f/taf tablets, their metabolites, or formulation excipient * females who are pregnant (as confirmed by positive serum pregnancy test) * females who are breastfeeding * acute hepatitis in the 30 days prior to randomization * active tuberculosis infection. note: other protocol defined inclusion/exclusion criteria may apply.